On July 22, 2025, the National Pharmaceutical Pricing Authority (NPPA) issued a new directive restricting annual price hikes for non-scheduled formulations and medical devices. As per the Office Memorandum (File No: 19(3)/2022/Div.II/NPPA), issued under Paragraph 20 of the Drugs (Price Control) Order (DPCO), 2013, manufacturers are prohibited from increasing the Maximum Retail Price (MRP) by more than 10% over the past 12 months.
Key Points from NPPA’s Regulatory Enforcement Order
- Mandatory rollback: If an MRP increase exceeds 10%, it must be reduced to comply with the permitted cap.
- Penalty enforcement: Manufacturers must deposit overcharged amounts with applicable interest. Legal action may be taken under the Essential Commodities Act, 1955.
- Brand price alignment: Manufacturers must ensure consistent MRP across brands of the same formulation or device to prevent wide price discrepancies.
- Strict Enforcement: The NPPA warns of penal consequences under DPCO, 2013 for non-compliance.
The directive, signed by Deputy Director (Enforcement) Manisha Khuntia, reinforces the NPPA’s ongoing effort to maintain price control over critical healthcare products and prevent arbitrary pricing in the medical device sector.
Why NPPA’s Action Matters for Medical Device Regulatory Affairs in India
Manufacturers cannot increase the MRP of non-scheduled formulations or medical devices by more than 10% over the last 12 months. Set your initial price carefully when launching in India, as exceeding this limit can lead to penalties and impact market access.
To see if your device falls under scheduled medical devices, click here
Pricing in a Storm
Navigating Currency Volatility in Global Distribution
Situation
A pricing conflict arose with an international distributor, driven by sharp currency fluctuations. The local partner experienced significant margin erosion due to USD-INR rate shifts.
The Trigger: Exchange Rate vs. MRP Freeze
The distributor requested a revision in the Maximum Retail Price (MRP) to account for the weakened currency. However, the MRP is fixed and standardized across regions to maintain brand integrity and ensure regulatory compliance.
Key Challenge: Changing MRP mid-cycle could disrupt global supply chain pricing consistency.
The Conflict: Fairness vs. Consistency
Allowing a one-off MRP revision based on forex shifts would risk setting a precedent, potentially leading to:
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Fragmented pricing policies across regions.
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Opacity in pricing structure.
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Erosion of partner trust and alignment
Solution Framework
1. Forex Impact Analysis
Quantified the real impact of currency devaluation versus existing margin buffers.
2. Alternate Compensation
Proposed structured alternatives to maintain partner viability.
3. Policy Reinforcement
Maintained consistency while showing flexibility within framework.
Alternate Compensation Proposed:
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Temporary volume-linked incentives
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Freight cost support
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Flexible credit terms (60–90 days)
Policy Reinforcement: Reiterated that MRP updates are part of an annual cycle and not reactive to short-term market volatility.
Broader Insight
Currency fluctuations are inevitable in global markets. The key is resilience in pricing strategy—offering flexibility within a consistent policy, rather than reactive price changes. Trust is built through predictability and structured accommodations.
How Morulaa, a Medical Device Registration Consultant in India, Can Help
As one of India’s largest medical device consultants, our team assists manufacturers with MRP compliance audits, brand price alignment strategies, NPPA communication, and documentation preparation to ensure full adherence to DPCO, 2013 regulations. We provide expert guidance on navigating regulatory scrutiny and help avoid penalties, ensuring manufacturers stay compliant and maintain market access through medical device regulatory services in India.
For a comprehensive regulatory review of your MRP compliance and NPPA alignment, reach out to the experts at Morulaa.
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